Trial record 2 of 11 for:    "Multicentric Castleman’s Disease"

A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01024036
First received: November 30, 2009
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial response) among patients with Multicentric Castleman's Disease.


Condition Intervention Phase
Multicentric Castleman's Disease
Drug: CNTO 328
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of CNTO 328 (Anti IL 6 Monoclonal Antibody) Plus Best Supportive Care Compared With Best Supportive Care in Subjects With Multicentric Castleman's Disease

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Number of patients that achieve a tumor and symptomatic response [ Time Frame: Up to 48 weeks after the last patient begins study treatment ] [ Designated as safety issue: No ]
    Tumor and symptomatic response may be either a complete response (CR) or a partial response (PR). CR is defined as a complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to Multicentric Castleman's disease, sustained for at least 18 weeks. PR is defined as a greater than or equal to 50% decrease in sum of the product of the diameters (SPD) of index lesion(s), with at least stable disease (SD) in all other evaluable disease in the absence of treatment failure, sustained for at least 18 weeks.


Secondary Outcome Measures:
  • Duration of tumor and symptomatic response [ Time Frame: Up to 48 weeks after the last patient begins study treatment ] [ Designated as safety issue: No ]
    It is defined as time from first documentation of tumor and symptomatic response (CR or PR) to treatment failure.

  • Number of patients with tumor response [ Time Frame: Up to 48 weeks after the last patient begins study treatment ] [ Designated as safety issue: No ]
    Tumor response is based on the assessment of index lesions (measurable) and nonindex lesions (non measurable).

  • Duration of Tumor Response [ Time Frame: Up to 48 weeks after the last patient begins study treatment ] [ Designated as safety issue: No ]
    It is defined as time from first documentation of tumor response (CR or PR) to tumor progression.

  • Time to Treatment Failure [ Time Frame: Up to 48 weeks after the last patient begins study treatment ] [ Designated as safety issue: No ]
    It is defined as the time from randomization to treatment failure.

  • Maximum change from baseline in hemoglobin value [ Time Frame: Baseline up to 48 weeks after the last patient begins study treatment ] [ Designated as safety issue: No ]
    Change in hemoglobin will be calculated as maximum change from baseline (in hemoglobin value) in the absence of transfusion.

  • Number of patients that discontinued corticosteroid therapy [ Time Frame: Up to 48 weeks after the last patient begins study treatment ] [ Designated as safety issue: No ]
    These are the number of patients who are able to discontinue corticosteroids, if they were corticosteroid dependent at study entry.

  • Change from baseline in relevant patient reported outcome scales [ Time Frame: Baseline up to 48 weeks after the last patient begins study treatment ] [ Designated as safety issue: No ]
    Changes versus baseline will be compared between cohorts.

  • Maximum observed serum concentration of CNTO 328 [ Time Frame: Up to 12 weeks after administration of last study drug infusion ] [ Designated as safety issue: No ]
    Maximum observed serum concentration of CNTO 328 will be measured when CNTO 328 is administered intravenously along with best supportive care.

  • Minimum observed serum concentration of CNTO 328 [ Time Frame: Up to 12 weeks after administration of last study drug infusion ] [ Designated as safety issue: No ]
    Minimum observed serum concentration of CNTO 328 will be measured when CNTO 328 is administered intravenously along with best supportive care.

  • Area under the serum concentration versus time curve of CNTO 328 [ Time Frame: Up to 12 weeks after administration of last study drug infusion ] [ Designated as safety issue: No ]
    Area under the serum concentration versus time curve of CNTO 328 will be measured when CNTO 328 is administered intravenously along with best supportive care.

  • Half-life of CNTO 328 [ Time Frame: Up to 12 weeks after administration of last study drug infusion ] [ Designated as safety issue: No ]
    Half-life of CNTO 328 will be measured when CNTO 328 is administered intravenously along with best supportive care.

  • Volume of distribution of CNTO 328 [ Time Frame: Up to 12 weeks after administration of last study drug infusion ] [ Designated as safety issue: No ]
    Volume of distribution of CNTO 328 will be measured when CNTO 328 is administered intravenously along with best supportive care.

  • Number of patients with antibodies to CNTO 328 [ Time Frame: Up to 12 weeks after administration of last study drug infusion ] [ Designated as safety issue: No ]
    Antibodies to CNTO 328 will be detected using a validated immunoassay. All samples collected for detection of antibodies to CNTO 328 will also be evaluated for CNTO 328 serum concentration to interpret antibody response data.

  • Number of patients with adverse events [ Time Frame: Up to 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: March 2010
Estimated Study Completion Date: February 2017
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CNTO 328
CNTO 328 11 mg/kg administered intravenously every 3 weeks.
Drug: CNTO 328
Type=exact number, unit=mg/kg, number=11, form=injection, route=intravenous. CNTO 328 will be administered every 3 weeks.
Placebo Comparator: Placebo
Placebo administered intravenously every 3 weeks.
Drug: Placebo
Form=injection, route=intravenous. Placebo will be administered every 3 weeks.

Detailed Description:

This is a multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), double blind (neither investigator nor the participant knows the treatment that the participant receives), placebo controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), study to assess the efficacy and safety of CNTO 328 plus BSC compared with BSC in patients with symptomatic Multicentric Castleman's Disease. The study mainly consists of 3 phases, including: the screening phase (majority of assessments performed within 28 days of first dose), the treatment phase, and the follow up phase. In the treatment phase, approximately 78 patients will be randomly assigned in 1:2 ratios to either of 2 treatment groups, ie, Treatment Group A: Placebo + BSC, or Treatment Group B: CNTO 328 + BSC. The follow up phase will be 3 months after last dose of study medication and the survival will be followed up until the study ends. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, patient-recorded temperature, and physical examination will be monitored throughout the study. The total study duration will be 5 years after the last patient starts study medication.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Measurable and symptomatic Multicentric Castleman's Disease
  • Adequate organ function as assessed by laboratory values evaluated by the investigator to determine eligibility prior to treatment
  • Eastern Cooperative Oncology Group performance status of 0, 1, or 2
  • Corticosteroids dose that does not exceed 1 mg/kg/day of prednisone, and has remained stable or decreased over the 4 weeks before treatment

Exclusion Criteria:

  • Human Immunodeficiency Virus or Human Herpes Virus-8 positive
  • Skin lesions as sole measurable manifestation of Multicentric Castleman's Disease
  • Previous history of lymphoma
  • Malignancies, except for adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or cancer other than lymphoma, from which the patient has been disease-free for 3 or more years
  • Concurrent medical condition or disease that may interfere with study participation
  • Prior exposure to Interleukin-6 or Interleukin-6 receptor targeted therapies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024036

  Show 55 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01024036     History of Changes
Other Study ID Numbers: CR016705, CNTO328MCD2001, 2009-012380-34
Study First Received: November 30, 2009
Last Updated: January 20, 2014
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission
Great Britain: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Taiwan: Department of Health

Keywords provided by Janssen Research & Development, LLC:
Multicentric Castleman's Disease
MCD
CNTO 328
Best Supportive Care
Tumor
Symptomatic response
Pharmacokinetics
Interleukin-6
IL6

Additional relevant MeSH terms:
Giant Lymph Node Hyperplasia
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014